Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QAF · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253840 | STEDI Scan Device | Stroke DX | 2026-07-22 | 233 | 0 |
| K182967 | Visor System | Cerebrotech Medical Systems, Inc. | 2018-11-23 | 28 | 0 |
| K171186 | Cerebrotech CMS-5000 | Cerebrotech Medical Systems | 2017-12-08 | 228 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda